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Archived Presentations to the IRB

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DatePresentations Provided to IRB Members
Aug 2015  • Non-compliance
July 2015  • Component Analysis
June 2015  • Children's Findings Signature Requirements
May 2015  • Children's Findings
Apr 2015  • Recruitment
Mar 2015  • Additional Documentation Needed for Approval
Feb 2015  • Non-Significant Risk Devices
Jan 2015  • Scientific & Scholarly Validity
Dec 2014  • IRB Member Conflicting Interests
Nov 2014  • CoI: Action Reports & Management Plans
Oct 2014  • Waiver of Documentation of Consent (waiver of signature)
Sept 2014  • Waivers and Alterations of Consent
Aug 2014  • HIPAA
July 2014  • Privacy vs. Confidentiality (pdf)
June 2014  • Expedited Review
May 2014  • Unanticipated Adverse Device Effect (UADE)
Apr 2014  • IRB Member Conflict of Interest (CoI)
Mar 2014  • Non-Significant Risk Devices
Feb 2014  • Conflict of Interest: Action reports & Management plans
Jan 2014  • Scientific Review & Scholarly Validity
Dec 2013  • Mobile Medical Apps
Nov 2013  • Recruitment
Oct 2013  • Waiver of Informed Consent
Sept 2013  • Waiver of Documentation (or signature) of informed consent
Aug 2013  • Preparing For AAHRPP: Criteria for Approval (Part 2)
July 2013  • Preparing For AAHRPP: Criteria for Approval (Part 1)
June 2013  • Preparing For AAHRPP: Unanticipated Problems
May 2013  • Preparing For AAHRPP: Non-Compliance
Apr 2013  • Preparing For AAHRPP: Expedited Review
Mar 2013  • Preparing For AAHRPP: the Role of the IRB Member
Feb 2013  • Preparing For AAHRPP: Introduction
Jan 2013  • Waiver of Documentation
Dec 2012  • Equitable Selection
Nov 2012  • Criteria for IRB Approval of Research (Part 2)
Oct 2012  • Criteria for IRB Approval of Research (Part 1)
Sept 2012  • Recruitment
Aug 2012  • Expedited Review Revisited (pdf)
July 2012  • Clinical Radiation Safety - Research with Children
May 2012  • Human Subjects Protocols: Privacy Considerations (pdf)
April 2012  • Children's Findings – Assent and Permission (pdf)
  • Children's Findings – Assent and Permission
March 2012  • Expanded Access (pdf)
  • Expanded Access
Feb 2012  • Pregnant Women (pdf)
  • Pregnant Women
Jan 2012
  • Phone Scripts, Questionnaires and Waivers of Documentation of Consent (pdf)
  • Phone Scripts, Questionnaires and Waivers of Documentation of Consent
Dec 2011

  • Regulations for SCRO Clinical Trials and ClinicalTrials.gov (pdf)

  • Additional Element of Consent: ClinicalTrials.gov (pdf)
  • Additional Element of Consent: ClinicalTrials.gov

Nov 2011
  • Informed Consent Requirements and Elements - Revisited (pdf)
  • Informed Consent Requirements and Elements - Revisited
Oct 2011
  • Provenance in Stem Cell Research (pdf)
Aug 2011
  • Issues with Tissues (pdf)
  • Issues with Tissues
Jul 2011
  • Events & Information that Require Prompt Reporting to the IRB (pdf)
May 2011
  • Unanticipated Problems (UPs) & Adverse Events (AEs) "more info" (pdf)
Apr 2011
  • Informed Consent Scenarios (Medical, pdf) 
  • Informed Consent Scenarios (Non-Medical, pdf)
Mar 2011  • Genetic Research: Basic Vocabulary and Terminology (pdf)
Feb 2011  • Data Safety Monitoring and the IRB (pdf)
Jan 2011  • Scientific and Scholarly Review (pdf)
Dec 2010  • Criteria for IRB Approval of Research (pdf)
Nov 2010  • Prisoner Research and the IRB (pdf)
Oct 2010  • Vulnerable Populations and Human Subjects Review (pdf)
Sept 2010  • Research Involving Children and Radiation Exposure (pdf)
Aug 2010

  • (A) Determination of Human Subject Research; 
    (B) Exempt Categories (pdf)

  • [SCRO] Updates to Stem Cell Research Oversight (pdf)

Jul 2010  • Certificates of Confidentiality (CoC) (pdf)
Jun 2010  • IRB Quiz (pdf)
May 2010  • Children in Research (Medical, pdf)
  • Children in Research (Non-Medical, pdf)
Apr 2010  • Expedited Review (pdf)
Mar 2010

  • Guidance on Unanticipated Problems (UPs) and Adverse Events (AEs)
    (Medical, pdf)
  • Guidance on Unanticipated Problems (UPs) and Adverse Events (AEs)     
    (Non-Medical, pdf)

  • CIRM Disease Team MPP Grants (Presentation to IRB 3/SCRO, pdf)

Feb 2010  • Ethnographical Research (Non-Medical, pdf)
Jan 2010

  • General Requirements for Informed Consent (Medical, pdf)
  • General Requirements for Informed Consent (Non-Medical, pdf)

  • SCRO Consent Requirements (pdf)

  • Stem Cell Terminology (pdf)

Dec 2009

  • Short Form Consent Process (pdf)

  • Sponsor-Investigator Research [SIR] and Investigational New Drugs [INDs] (pdf)

Nov 2009

  • Criteria for IRB Approval of Research (Medical, pdf)
  • Criteria for IRB Approval of Research (Non-Medical, pdf)

  • A Guide for the Combined IRB/SCRO (pdf)

Oct 2009

  • IRB Member Orientation (pdf)

  • Resources Supporting the HRPP (pdf)

Sept 2009  • Funding Research (pdf)
Aug 2009  • HIPAA (pdf)
July 2009  • Understanding Waivers & Alterations of Consent (pdf)
Jun 2009  • Laboratory Employees and Students as Research Subjects (pdf)
May 2009  • Belmont Report - History, Principles and Application (pdf)
Apr 2009  • IRB Determinations about Parental Permission (pdf)
Mar 2009

  • Additional Protections for Pregnant Women, Fetuses and Neonates (pdf)

  • Survey Research in Public Schools (PPRA Regulation, pdf)

Jan 2009  • AAHRPP Site Visit - December 2008 (pdf)